On Jan. 26, 2015, generic Lamictal was officially released into the American market and will soon be available for sale to awaiting customers. Impax Laboratories, the manufacturer, will be bringing out global marketing initiatives for their new product and is optimistic for their investment.

Impax had obtained the exclusive right to market the drug for the first 180 days of its release in July 2014, after Actavis plc approved its Abbreviated New Drug Application (ANDA) to produce generic Lamictal. Like its brand-name predecessor Lamictal, this drug will be prescribed to patients with specific kinds of epilepsy, most commonly Lennox-Gastaut Syndrome.

Brand-name Lamictal has proven to be a successful venture for GlaxoSmithKline, garnering $56M for the company in November 2014. Lamictal can be used alone or in conjunction with other medications to treat these specific conditions, and can be prescribed to adult and pediatric patients. According to medical experts, Lamictal works by blocking certain sodium channels in the brain, which prevents seizures and has proven to be an effective mood stabilizer.

Beyond its well-known treatment mechanism, the medical community has come to know this drug for the severe Lamictal side effects. In particular, Lamictal has been associated with the severe reactions known as Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). It is one of the most commonly mentioned medications on SJS and TEN injury reports, with severe skin rashes mentioned as a possible side effect on Lamictal’s label.

Even with Impax’s efforts to make their generic version of Lamictal a success, it will still have to contend with the brand-name’s infamy of being associated with SJS. This condition is known for causing permanent skin damage to patients, causing vision loss, and potentially permanent internal organ damage. So naturally, a pharmaceutical company could find themselves in hot water if they fail to mention such as severe side effect on their drug’s warning label, but many don’t.

Overview of Stevens Johnson Syndrome

Lamictal’s warning label does not specifically mention SJS being a possible side effect, but does mention many SJS symptoms, including severe skin rashes, fever, and hives. Stevens Johnson Syndrome is a severe allergic skin reaction, which is famously characterized for the red or purple skin lesions that causes the patient’s skin to detach from the body. Typically, SJS can cover up about 30 percent of skin surface area, compared to TEN which can take up to as much as 90 percent.

Stevens Johnson Syndrome progresses quickly and can be fatal if not diagnosed in time. It is important to note that both pediatric and adult patients have died from this condition. Along with the detaching skin and possible infections, internal organ damage is one of the injuries that SJS can inflict. Due to the nature of these injuries, SJS patients are often treated in the burn unit of hospitals.

Medical experts warn that SJS is more likely to occur if more than one medication is being taken, and if the patients have a family history of drug allergies. If it does occur, it will be within the first two to eight weeks of starting the medication, and will start with flu-like symptoms. More than 100 medications have been determined to cause Stevens Johnson Syndrome, but only 300 cases are diagnosed per year in the United States.

It remains to be seen if Impax will be successful, but healthcare providers highly encourage patients to pay attention to themselves when taking any new medications and recommend that pharmaceutical companies be as forthcoming as possible about their drugs’ side effects.